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    Summary
    EudraCT Number:2012-003600-12
    Sponsor's Protocol Code Number:12001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-08-23
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-003600-12
    A.3Full title of the trial
    The effect of cold air on the airways of elite skaters and the protective role of the OMRON
    De beschermende rol van de OMRON op het effect van droge, koude lucht op de luchtwegen van eliteschaatsers
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of cold air on the airways of elite skaters and the protective role of the OMRON
    De beschermende rol van de OMRON op het effect van droge, koude lucht op de luchtwegen van eliteschaatsers
    A.3.2Name or abbreviated title of the trial where available
    OMRON and elite skaters
    A.4.1Sponsor's protocol code number12001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSportmedisch expertisecentrum
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNo other organisations are involved
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSportmedisch Expertisecentrum
    B.5.2Functional name of contact pointJean Driessen
    B.5.3 Address:
    B.5.3.1Street AddressThialfweg 41
    B.5.3.2Town/ cityHeerenveen
    B.5.3.3Post code8441 PW
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310513486486
    B.5.6E-mailjean.driessen@tjongerschans.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Ventolin
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSalbutamol
    D.3.2Product code R03CC03
    D.3.4Pharmaceutical form Inhalation vapour, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboNebuliser solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Exericise induced bronchoconstriction
    Inspanningsgeïnduceerde luchtwegobstructie
    E.1.1.1Medical condition in easily understood language
    Exercise induced asthma
    Inspanningsastma
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Analyze the effect of nebulized salbutamol or isotonic saline on exercise induced airway obstruction measured with a fall in FEV1 in elite speed skaters
    Het effect van salbutamol en isotoon zout op inspanningsgeïnduceerde luchtwegobstructie, gemeten met een daling in de FEV1 bij toptopschaatsers
    E.2.2Secondary objectives of the trial
    - Analyze the effect of nebulized salbutamol or isotonic saline on exercise induced airway obstruction measured with a change in airway resistance in elite speed skaters
    - Analyze the effect of nebulized salbutamol or isotonic saline on exercise induced airway obstruction measured with a change in airway reactance in elite speed skaters
    - Analyze the effect of nebulized salbutamol or isotonic saline on exercise induced airway obstruction measured with a change in EMG activity or breathing musclesin elite speed skaters
    -Het effect van salbutamol en isotoon zout op inspanningsgeïnduceerde luchtwegobstructie, gemeten met een verandering van weerstand bij toptopschaatsers
    -Het effect van salbutamol en isotoon zout op inspanningsgeïnduceerde luchtwegobstructie, gemeten met een verandering van reactantie bij toptopschaatsers
    Het effect van salbutamol en isotoon zout op inspanningsgeïnduceerde luchtwegobstructie, gemeten met een verandering van EMG activiteit bij toptopschaatsers
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age between 18 and 35 years
    - Elite speedskater
    - Women: 1500 meter time below 2:10:00 minutes.
    - Men: 1500 meter time below 02:05:00 minutes.
    These times should have been skated within a period of two months prior to study measurement.
    - Able to undergo reproducible lung function tests. Three-fold repetition of FEV1 measurements, with a mutual difference of maximal 5 percent
    - Leeftijd tussen de 18 en 35 jaar
    - Topschaatser
    - Vrouwen: 1500 meter in 2:10:00 minuten, <2 maanden van de test.
    - Mannen: 1500 meter in 02:05:00 minuten, <2 maanden van de test.
    - Longfunctie kunnen blazen, (3 maal FEV1 <5%)
    E.4Principal exclusion criteria
    - Ultrasonic nebulization within 48 hours before testing.
    - FEV1 <70% of predicted.
    - Respiratory infection within 6 weeks prior to examination for which medication should be prescribed.
    - Ultrasone verneveling <48 uur van de test
    - FEV1 <70% van voorspeld.
    - Luchtweg infectie <6 weken voor de test, waarvoor medicatie moet worden voorgeschreven
    E.5 End points
    E.5.1Primary end point(s)
    -The difference in exercise induced fall of FEV1 after four minutes of treatment with salbutamol compared to nebulization with with salbutamol, 0.9% NaCl and controls.
    - het verschil in daling van de FEV1 na 4 minuten behandeling met salbutamol (1mg), isotoon zout, of geen verneveling
    E.5.1.1Timepoint(s) of evaluation of this end point
    10, 15 and 30 minutes after exercise
    10, 15 en 30 minuten na inspanning
    E.5.2Secondary end point(s)
    -Analyze the change in exercise induced increase of airway resistance, measured with the FOT, after four minutes of treatment with salbutamol, 0.9% NaCl and controls.
    -Analyze the change in exercise induced decrease of airway reactance, measured with the FOT, after four minutes of treatment with salbutamol, 0.9% NaCl and controls.
    -Analyzing the change in the electro physiological activity of the respiratory muscle system, measured with EMG with Salbutamol ,isotonic saline and controls.
    - Het verschil in verandering van weerstand tussen de onderzoeksgroepen
    - Het verschil in verandering van reactantie tussen de onderzoeksgroepen
    - Het verschil in verandering van EMG activiteit tussen de onderzoeksgroepen
    E.5.2.1Timepoint(s) of evaluation of this end point
    10, 15 and 30 minutes after exercise
    10, 15 en 30 minuten na inspanning
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Contyrole groep zonder interventie
    Control gorup without intervention
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    the end of the trial is after the elite skater is informed of his/her test outcome.
    het einde van de trial is als de topschaatser is geïnformeerd over de uitslag van diens test.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 41
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-08-23. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Elite speedskaters
    Topschaatsers
    F.4 Planned number of subjects to be included
    F.4.1In the member state41
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Infrorming the athletes of the outcome of their test
    De atleten worden na de test geïnformeerd over de uitslag
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-29
    P. End of Trial
    P.End of Trial StatusOngoing
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